Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Confocal Endomicroscopy During Endoscopy

11. oktober 2018 opdateret af: University of Alberta

Confocal Endomicroscopy in Patients Undergoing Endoscopy

The main objective of this study is to determine the role of epithelial cell homeostasis in the pathogenesis of intestinal diseases.

Background: Alterations in intestinal barrier function may play a significant role in the pathogenesis of chronic intestinal diseases such as inflammatory bowel disease (IBD). The intestinal epithelium functions as a barrier to the luminal contents, thereby preventing undesirable solutes, micro-organisms and other luminal antigens from entering the body. Confocal endomicroscopy has recently been shown that increased epithelial cell shedding may contribute to increased intestinal permeability, at least locally. In our study, we want to determine the contribution of epithelial cell shedding to intestinal permeability in vivo in patients with inflammatory bowel disease compared to controls.

Scope:

In inflammatory bowel disease patients and controls (patients undergoing endoscopy for other indications).

Methods:

We will perform confocal endoscopy during the patient's endoscopic procedure.

Procedure:

The patient will receive intravenous fluorescein, followed by confocal imaging of the gastrointestinal tissue. The images are captured on the computer. The proposed study will provide important insights into epithelial cell shedding as a contributor to altered intestinal permeability.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

220

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients undergoing endoscopy: study group are patients evaluated for IBD symptoms and control patients for other indications such as colon cancer screening, positive fecal occult testing, constipation or diarrhea.

Beskrivelse

Inclusion Criteria for patients includes:

  1. Subjects over 18 years of age.
  2. Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included.

Exclusion Criteria:

  1. Under 18 years of age.
  2. Cognitively impaired.
  3. Residing in institutions (eg. prison, extended care facility)
  4. Employees of research(s)' organization
  5. In emergency or life-threatening situations
  6. Have language barriers (eg. illiterate, not English-speaking, dysphasic) preventing adequate consent process
  7. Resides in another country

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Control
In patients undergoing endoscopy for indications other than Crohn's disease or ulcerative colitis
Enhed: Confocal endomicroscopy
Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the control group will be compared to the diseased group.
Andre navne:
  • laser confocal endomicroscopy
Enhed: Confocal endomicroscopy
Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the diseased group will be compared to the control.
Andre navne:
  • laser confocal endomicroscopy
Diseased group
Patients with Crohn's disease or ulcerative colitis undergoing endoscopy.
Enhed: Confocal endomicroscopy
Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the control group will be compared to the diseased group.
Andre navne:
  • laser confocal endomicroscopy
Enhed: Confocal endomicroscopy
Patients will undergo confocal endomicroscopy during their endoscopy, and findings of the confocal endomicroscopy in the diseased group will be compared to the control.
Andre navne:
  • laser confocal endomicroscopy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The intestinal morphology as visualized using confocal laser endomicroscopy
Tidsramme: 3 years.
Intestinal morphology as measured by epithelial cells and gaps, presence of bacteria in the epithelial lining and the lamina propria will be quantitated.
3 years.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical outcome and pathologic/molecular correlation with intestinal morphology
Tidsramme: 3 years.
The clinical outcomes of inflammatory bowel patients, location and severity of their disease, and correlation with molecular studies including tissue cytokine levels will be studied.
3 years.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Alberta

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2009

Primær færdiggørelse (Faktiske)

1. december 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

1. oktober 2009

Først indsendt, der opfyldte QC-kriterier

1. oktober 2009

Først opslået (Skøn)

2. oktober 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. oktober 2018

Sidst verificeret

1. april 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20090821300

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Inflammatorisk tarmsygdom

Kliniske forsøg med Confocal endomicroscopy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Liberia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner